BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1674429 · Received May 4, 2010

    Report

    Report Number
    2024601-2010-00307
    Event Type
    Death
    Date Received
    May 4, 2010
    Date of Event
    April 4, 2010
    Report Date
    April 5, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE RETURN OF THE DEVICE FOR PRODUCT ANALYSIS WAS REQUESTED. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEATH, CARDIOPULMONARY ARREST, HEMORRHAGE, EROSION, NECROSIS, PAIN, AND VOMIT ARE SURGICAL AND PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR THE EXPLANT DATE. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF DEATH AND HEMORRHAGE AS FOLLOWS: "LAPAROSCOPIC OR LAPAROTOMIC PLACEMENT OF THE LAP-BAND SYSTEM IS A MAJOR SURGERY AND DEATH CAN OCCUR. SPECIFIC COMPLICATIONS OF LAPAROSCOPIC SURGERY CAN INCLUDE SPLEEN DAMAGE (SOMETIMES REQUIRING SPLENECTOMY) OR LIVER DAMAGE, BLEEDING FROM MAJOR BLOOD VESSELS, LUNG PROBLEMS, THROMBOSIS, AND RUPTURE OF THE WOUND." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN EROSION AS FOLLOWS: "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE. RE-OPERATION TO REMOVE THE DEVICE IS REQUIRED. CAUTION: AS WITH OTHER GASTROPLASTY SURGERIES, PARTICULAR CARE MUST BE TAKEN DURING DISSECTION AND DURING IMPLANTATION OF THE DEVICE TO AVOID DAMAGE TO THE GASTROINTESTINAL TRACT. ANY DAMAGE TO THE STOMACH DURING THE PROCEDURE MAY RESULT IN EROSION OF THE DEVICE INTO THE GI TRACT." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AND VOMIT AS FOLLOWS: "OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ABDOMINAL PAIN, CHEST PAIN, INCISION PAIN, AND PORT SITE PAIN. NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PT EATS MORE THAN RECOMMENDED."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED, THE DEATH OF A PT FOLLOWING IMPLANTATION OF THE LAP-BAND SYSTEM. THE PT WAS RETURNED TO SURGERY AS THE RESULT OF SEVERE ABDOMINAL PAIN AND VOMITING WITH INABILITY TO RETAIN FLUIDS OR FOOD. DURING THE SURGERY, THE SURGEON DISCOVERED AN EROSION OF THE BAND AND NECROSIS OF THE BOWEL AND ESOPHAGUS. THE PT HEMORRHAGED AND SUFFERED CARDIOPULMONARY ARREST DURING THIS SURGERY AND WAS PLACED ON LIFE SUPPORT AND KIDNEY DIALYSIS. THE PT DIED FROM MULTIPLE ORGAN FAILURE AND WAS TAKEN OFF LIFE SUPPORT. PER THE REPORTING HEALTHCARE PROFESSIONAL, PRIOR TO DEATH, THE PT HAD A HIGH WHITE BLOOD COUNT BUT DID NOT HAVE A FEVER. F/U WITH THE SURGEON AND THE MEDICAL FACILITY IS IN PROGRESS AT THIS TIME. ALLERGAN HAS NOT RECEIVED ANY ADDITIONAL INFO IN THIS CASE SO FAR, AND THE DEVICE WAS NOT RETURNED TO US FOR PRODUCT ANALYSIS. ANY NEW INFO WILL BE FORWARDED TO THE FDA IN A F/U REPORT UPON RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death